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Breast Reconstruction Options after Mastectomy

Many breast surgeons and breast cancer patients believe that breast reconstruction is an important step in recovering physically and mentally from a mastectomy.  Research shows that women who undergo flap procedures (described below) have a better quality of life after reconstruction than women undergoing reconstruction with breast implants.[1] However, not all women are able to undergo those procedures.  Unfortunately, many patients are not given complete information about the different options for breast reconstruction, including the risks and benefits of each.  In fact, a recent study showed that only 43% of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.[2]

The Women’s Health and Cancer Rights Act of 1998 is a law that requires that private insurance companies pay for breast reconstruction if they pay for mastectomies.  This includes reconstruction on the removed breast, modification of the other breast to create a symmetric appearance, and treatment of any complications that result from a mastectomy or reconstruction.  The forms of reconstruction covered may vary by state and insurance provider, so it is important that you call your insurance provider to see which options will be covered in your particular case.[3]

This article does not provide medical advice, but we provide information based on scientific research and from speaking to many experts in the field.  We recommend discussing your treatment options with a physician whom you trust.  As a patient, you have the right to seek more than one medical opinion.

Which Type of Breast Reconstruction is Best?

The decision of which reconstruction option to choose, if any, is a personal one.  To make an informed choice, however, patients need to meet with breast surgeons who are skilled at the different options.  Since most breast surgeons only know how to do reconstruction with breast implants, they don’t usually provide good information to their patients about the benefits of other options.

There are several studies which look at the long-term outcomes for each of the reconstruction options, and these can help patients to make a decision.

For example, a study published in 2018 analyzed over 2000 reconstruction patients and found that patients who undergo autologous breast reconstruction (“flap” procedures) are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  After two years, patients who chose to get flap procedures reported having a better quality of life than patients who got breast implants.  Some of the areas in which the flap patients reported greater satisfaction include their psychosocial, physical, and sexual well-being.[1]

The researchers also found differences in surgery-related complications within the first 2 years after surgery.  Flap procedures have significantly higher rates of short-term surgery-related complications that occur immediately following surgery.  In contrast, breast implants have more surgery-related complications that occur weeks or months after the surgery is completed.  [4] In addition, women are likely to need multiple surgeries to replace implants over their lifetime.[4]

A description of the options for reconstruction is below.

Reconstruction with Breast Implants

Breast implants are the most common form of breast reconstruction after mastectomy.  [5].  This is probably because breast implants are the easiest form of reconstruction and most plastic surgeons are not skilled enough to perform the other types of breast reconstruction discussed below.  There are silicone gel breast implants and saline breast implants on the market, and both options have a high complication rate for reconstruction patients.  You will probably be told that breast implants are not lifetime devices, but that’s an understatement.  Studies by researchers and by implant manufacturers have shown that after three years, most reconstruction patients will have at least one serious complication.[6][7] Below are some of the most common complications of breast implants.

In addition, women who have breast implants, either for mastectomy or healthy breasts, are more likely to develop a type of lymphoma (cancer of the immune system) called ALCL[8]

You can read more about risks and complications related to breast implants here and more about the different types of breast implants here.  Despite the risks, some women get implants because they are not good candidates for other types of breast reconstruction.  Women who are very thin or very physically active, have poor veins, or who may become pregnant in the near future may not be good candidates for other reconstruction options.

Reconstruction with Autologous Tissue Transfer (Flap Procedures)

Autologous tissue transfer (also known as a flap or flap procedure) refers to any procedure in which the body’s own tissue is used to reconstruct breasts.  Surgeons take fat and other tissue from another part of a woman’s body and move it to create breasts.  Sometimes, implants are used along with the tissue transfer to create larger breasts.  When implants are used with flap procedures, the risk for complications is higher than for either procedure alone.  For that reason, it makes sense to choose either flap reconstruction or implants but not both.

There are various types of autologous tissue transfer as described below.

Flap Reconstruction with Muscle and Fat

In this procedure, surgeons take muscle and fat from other areas of the body and move it to the breast area.  The most common form of this procedure is the TRAM flap, which uses muscle and fat from the abdomen.  While using stomach muscle is typical, surgeons can also take muscle from the inner thigh or buttocks.  Reconstruction methods using fat and muscle create a more natural looking reconstruction than those using only fat due to their added firmness.   Also, the larger amount of tissue used during muscle and fat reconstructions enables the surgeon to create larger breasts than those with fat only.  A drawback to this type of surgery is its complexity.  Veins and arteries must be reattached to the muscle and fat, so this surgery requires an experienced vascular surgeon.  Even with a good surgeon, this surgery isn’t 100% successful.  However, if it is successful, these reconstructed breasts can last a lifetime.   But, if muscle is removed from the abdomen, the women will not have as much strength there as they did before.[10]

Flap Reconstruction with Fat Only

Some reconstructions are performed using only fat.  The most common form of this is the DIEP flap, which takes skin, vessels, and fat from the abdomen but spares the muscles.  Surgeons can take tissue from most areas of the body that have a large fat supply.[10] Reconstruction with only fat takes more time than other procedures because the tissue has to be harvested and removed from the body before the reconstruction can take place.[11] To be a good candidate for this procedure, women need more body fat to create the breast.  This means that women with low body fat or poor vascularity may not be good candidates for this surgery.  The difficulty of this form of reconstruction are similar to those of reconstructions done with muscle and fat.  However, since no muscle is used, patients should not expect to permanently lose strength in any part of their body.[10]

Reconstruction with the Latissimus Dorsi

This surgery, commonly known as Lat flap, uses the latissimus dorsi muscle to reconstruct breasts.  The latissimus dorsi is a muscle of the upper back that extends around the side of the body. This procedure is more likely to fail than some other flap procedures, but less likely to have surgery-related complications or need reoperations within the first two years.[4]

Lat flap can be performed on women who do not have enough body fat for other forms of autologous reconstruction, and is frequently used with breast implants.  Some surgeons prefer it because the only visible scar will be from the mastectomy, and because the muscle can remain attached to its original blood source, which lowers the chance of the tissue dying after transfer.  However, since the latissimus dorsi is a large and important back muscle, the procedure can lead to serious difficulties moving, lifting, or performing strenuous exercise.  Patients who choose this option can also expect to get fatigued more easily.[10]

It’s Your Choice

As you can see from the research above, flap procedures are a very good choice for women who want a lifetime solution that avoids the complications typical of breast implants, and the possible risk of developing lymphoma.  However, fewer doctors perform flap procedures.  They are also longer and more complicated surgeries than reconstruction using breast implants.  For this reason, it is extremely important that women choosing a flap procedure go to a surgeon who is very experienced in autologous reconstruction.

When making a reconstruction decision, it is important for each woman to weigh the risks and benefits of each procedure with a doctor that is capable of these different options, so that she can make a decision that is right for her.

  1. Santosa, K.B., Qi, J., Kim, H.  M.  (2018). Long-term patient-reported outcomes in postmastectomy breast reconstruction. JAMA Surgery.
  2. Lee, C.  N., Deal, A.  M., Huh, R.  (2017). Quality of patient decisions about breast reconstruction after mastectomy. JAMA Surgery. 152(8): 741-748.
  3. Center for Medicare and Medicaid Services. (n.d.). The center for consumer information & insurance oversight: Women’s Health and Cancer Rights Act. Retrieved Aug, 2018.  From <https://www.cms.gov/CCIIO/Programs-and-Initiatives/ Other-Insurance-Protections/ whcra_factsheet.html>
  4. Bennett, K.  G., Qi, J., Kim, H.  M. (2018). Comparison of 2-year complication rates among common techniques for postmastectomy breast reconstruction. JAMA Surgery.
  5. American Society of Plastic Surgeons. (2014). 2014 Plastic Surgery Statistics Report.
  6. Food and Drug Administration. (October 14, 2003). General and Plastic Surgery Panel: McGhan silicone-Filled Breast Inplants. Retrieved Aug, 2018.  From <https:// wayback.archive-it.org /7993/20170404080858/https://www.fda.gov/ ohrms/ dockets/ac/03/slides/3989s1.htm>
  7. Food and Drug Administration. (March 2, 2005). Mentor P03003 – FDA Summary Panel Memorandum.  Retrieved Aug 2018. From <https://wayback.archive-it.org/ 7993/20170405093726/https://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4101b1_Tab-1_fda-Mentor%20Panel%20Memo.pdf>
  8. Food and Drug Administration. (Apr 6, 2018). Risks of Breast Implants. Retrieved Aug 2018.  From <https://www.fda.gov/medicaldevices/productsandmedicalprocedures /implantsandprosthetics/breastimplants/ucm064106.htm>
  9. Brown, S. L., Duggirala, H. J., Penello, G. (2002). An association of silicone-gel breast implant rupture and fibromyalgia. Current Rheumatology Reports. 4(4): 293-298.
  10. Teymouri, H.R., Stergioula, S., Eder, M., Kovacs, L., Biemer, E., Papadopulos, N.A.  (2006). Breast reconstruction with autologous tissue following mastectomy. Hippokratia.  10(4): 153-162.
  11. Somogyi, R. B., Ziolkowski, N., Osman, F., Ginty, A., Brown, M. (2018). Breast reconstruction: updated overview for primary care physicians. Canadian Family Physician.

Breast Implants Have Harmed Me. How Can I Report this to the FDA?

 


Breast implants do not last a lifetime and many women report complications that they did not expect. Many women with breast implants experience implant rupture, capsular contracture, breast or body pain, joint pain and other autoimmune symptoms, mental confusion, rashes, and even cancer of the immune system (ALCL). If you have experienced any of these complications, you could help other women by reporting it to the FDA.

The FDA is responsible for protecting patients and consumers by warning them about the risks of medical products, and taking products off the market if the risks outweigh the benefits.  The main way they gather information about the risks of breast implants (and other types of implants) is when doctors, nurses, and patients report problems through the FDA’s Voluntary MedWatch Report. If the FDA sees that complications are more serious or more frequent than expected, we will urge them to require manufacturers to conduct better research or to pull the product from the market.

You can report any problems caused by your breast implants using this short online form.

You don’t need to remember exactly when the symptoms or complications started, but give an estimate of how long it was after you got your implants.  If you don’t know the exact brand or model of your implant, you should report your problems anyway, but include the brand if you can.  From 2000 to 2015, most breast implants in the US were made  by either Mentor or Allergan (also called Inamed or McGhan).

If you are in Canada, you can report medical device complications to Health Canada using this short online form.

If you have problems completing the form, ask for help at info@center4research.org

The Human Tragedy of Poorly Regulated Medical Devices Gets the Spotlight in a Netflix Film

Amy Martyn, Consumer Affairs: July 27, 2018.


The motel where Ana Fuentes arrives one evening with her young daughters charges $110 for a single night and doesn’t offer weekly discounts. Fuentes asks the cashier for a moment so she can think about it.

Outside, the camera captures an anguished look on her face. It’s clear she can’t afford the expense. She books the room anyway. “Do you like it?” she asks her girls as they excitedly unpack their bags.

The family used to have an apartment, but Fuentes had to visit the emergency room so often that she lost her job, her daughters explain on camera.

Such situations aren’t rare in the United States, where experts have repeatedly warned that millions of Americans have almost nothing in savings and are a single medical disaster away from financial ruin. The problem is compounded nationwide by costly healthcare, lack of access to paid sick leave in the workforce, or a combination of the two.

But Fuentes’ story, like dozens of others featured in an upcoming expose about the medical device industry, has a particularly cruel twist. She says in the film that she was healthy until a doctor convinced her to undergo what was supposed to be a routine, non-surgical medical procedure — getting small birth control implants permanently embedded into her fallopian tubes.

The $155 billion medical device industry has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face from elected officials and others. On Friday, a documentary about the device industry and patients like Fuentes called The Bleeding Edge is set to go live on Netflix, bringing what advocates hope will be widespread attention to an industry increasingly characterized by lax safety standards, enormous power in the operating room, and horrific side effects.

“If you’re going to have something implanted in your body for potentially the rest of your life, wouldn’t you like it to be really well-tested beforehand? Is that really too much to ask?” says Dr. Diana Zuckerman, a health policy analyst who has worked in the White House and as a staffer in Congress.

The current president of the National Center for Health Research, Zuckerman and the other researchers at her non-profit are among the few to have taken interest in faulty medical devices.  

Diving into the medical device industry

Hollywood directors Kirby Dick and Amy Ziering knew they wanted to make a documentary film about preventable medical injuries, Dick tells ConsumerAffairs, but that was about it.

Sitting in on one patient advocacy meeting for research, they caught a presentation that Zuckerman gave about the medical device industry and the ease with which questionable products get on the market. They decided that they had found their story.

The team interviewed approximately 70 patients to make their film, Dick tells ConsumerAffairs. The film also includes interviews with numerous whistleblowers, such as doctors, former Food and Drug Administration (FDA) researchers, and one medical device sales rep who requested anonymity in exchange for speaking on camera.

Dick and Ziering were previously nominated for an Oscar for The Hunting Ground, their documentary about sexual assault on college campuses. Another earlier film, The Invisible War, is an expose about sexual assault in the military.

But persuading people to speak out against the device industry made for the most challenging interviews they’ve done, Dick tells ConsumerAffairs. (A medical device industry lobbyist touts in one scene that the industry is more powerful than some national governments.)

The “E-sisters”

As the film and the research it is based on shows, the problem is bigger than any single device. The Bleeding Edge captures the story by focusing  on four implants — three of which were used exclusively women’s reproductive organs.

The narrative is driven forward by the story of the “E-sisters,” or the activists who say that they suffered debilitating side effects after receiving the permanent birth control implant Essure.

For years, the “E-sisters” have organized a grassroots campaign to convince regulators to ban Essure from doctors’ offices. That goal seemed like an uphill battle until last week, when Bayer suddenly released an announcement that Essure will no longer be sold in the United States by the end of the year.

Bayer frames the move as a “business decision.” The announcement came one week before the Netflix documentary was scheduled for release.

“I’m very glad that these issues are getting this kind of attention, and I hope that Bayer’s decision to take Essure off the market won’t take away from the bigger message of the film,” says Zuckerman, “which is the whole process for devices that makes no sense at all.”

“Why in the world would you want to have a regulatory agency in our government, the FDA, having much lower standards for devices than they do for prescription drugs?”

Essure implants

The story of Essure, in particular, only saw the light-of-day thanks to the “E-sisters,” who count 30,000 people in their Essure Problems Facebook group and have convinced numerous elected officials, doctors, and even early clinical trial participants to join their cause.

“One of the things that is disturbing to me is that these issues only came to light because of the work of victims,” former Representative Mike  Fitzpatrick (R-Pa.) said in an interview several years ago.

Women who agreed to participate in clinical trials for Essure in the late 90s have said that they there were sold on a pitch to get a free, non-hormonal, and permanent birth control that was already proven safe.

A nickel coil, the size of a ballpoint pen, would be placed in each fallopian tube. That was designed to create an inflammatory response so that the coils would become permanently encased in the resulting scar tissue.

Regulators with the FDA approved the device in 2002, despite admitting that they knew little about the long-term side effects of such a procedure, as footage that the E-sisters had obtained captures. What’s more, numerous clinical trial participants later said that their painful side effects were not included in the company’s official data.

Doctors not long after began using the devices without questioning potential risks. “For some reason we did that to women. And I did that, too,” Dr. Shawn Tassone, an Austin-based gynecologist, tells ConsumerAffairs.

Insurance and profit margins

The sales representatives who taught doctors how to place the devices — something that Bayer has defended as a common industry practice — offered no instructions on how the device should be removed if there were side effects.

“We were just told from the very beginning that even if they’re misplaced, you don’t have to remove them,” Tassone remembers.

The role that insurance coverage may have played isn’t examined specifically in The Bleeding Edge, but testimony from patients and doctors suggests that getting insurers to cover Essure proved much easier than getting them to cover removal.

Tassone remembers that both private plans and Medicaid paid fairly generously for the Essure procedure, especially considering that inserting Essure was much cheaper and less labor-intensive than tubal surgery, the older sterilization procedure.

“If you think about a tubal ligation where you go to the operating room, it’s $400 [in profit] give or take,” he say. “Essure in the office, after you subtract the amount of the device, it’s probably $1100.”

Treating any resulting side effects proved impossible for women navigating unfamiliar territory. Angie Firmalino, the New York City mail carrier who founded the E-sisters network, initially seeked help from a doctor who morcellated the coils into small pieces — sending the nickel elsewhere in her body.

Connecting patients with doctors who are willing and able to properly remove the devices, as well who are able to code it correctly so that insurance will pay, has since become one of the E-sister’s major tasks.

Tassone, for his part, implanted his last Essure device in 2013. He says it was a call from another doctor who convinced him not to perform the procedure anymore; a woman with Essure apparently had gotten pregnant, he was told, which can be extremely dangerous for both the baby and the mother. One researcher has counted 303 fetal deaths linked to the device.

Tassone has since switched sides, counseling the E-sisters online and in the operating room. He estimates that he has conducted 600 Essure removal surgeries.

Trust remains despite ban

In recent years, the advocates have convinced the FDA to add a black box warning to Essure. Later on, they were able to help pass a rule which requires doctors to give patients more detailed warnings about the product.

But that didn’t appear to stop most doctors from trusting the device. The American College of Obstetricians and Gynecologists continues to say on its website that lasting pain from the procedure is “rare.” By contrast, nearly 27,000 reports have been filed to the FDA’s “adverse event” report database describing health problems caused by Essure and 16,000 lawsuits have been filed here. An estimated 750,000 women worldwide have undergone the procedure.

Now that Essure is off the market, doctors may be more willing to attempt removal surgery, Tassone says, something he thinks is necessary but frightening

“They’re going to think its not a big deal to take out,” he worries. (More detailed advice about removal surgeries is offered on the Essure Problems page).

Generally, before any major surgery involving a permanent implant, researchers advise patients to press doctors on the specific devices that will be used. Zuckerman, the health policy analyst who helped inspire the Netflix film, recalls that even she struggled to get specific answers when she asked a doctor what brand of hip he would choose for her own surgery.

The procedure ultimately went well, she says, but trying to search for good data comparing brands beforehand was nearly impossible.

“In the vast majority of cases, the surgeons are still quoting the company data,” Zuckerman says. “The company’s data on humans is nonexistent —  at least publicly.”

Breast Implant Illness: Two Metro Women Say Implants Caused Years of Complications

Ben Oldach, WHO TV: May 21, 2018

Breast implants are the most popular form of plastic surgery in the United States. Katie Krug’s followed a botched breast reduction.

“There were quite a few people that asked me when I was in a bathing suit if I had open heart surgery, so it was something that I was really self-conscious about,” said Krug. […]

“About a year later is when I started noticing some really small symptoms. I was tired a lot more, started having some brain fog, started being really sensitive to smells, and then it just seemed like every year it got worse,” said Krug. […]

Both women say they went to doctors who couldn’t figure out what was wrong, all while new symptoms were developing. […] and after doing some research found a Facebook group of 35,000 women, all claiming similar symptoms.

The women in the group believe they are suffering or had suffered from something being called breast implant illness, although experts say it’s a symptomatic reaction rather than an actual disease. […]

Miller and Krug consulted with a local plastic surgeon who performs explants and had theirs removed. They say they immediately started feeling better. […]

Read the original article here.

After 17 Years with Breast Implants, Princeton Woman Leads Calls for More Education, Safety

Marie Saavedra, WFAA: April 16, 2018

A North Texas woman says her implants were making her sick. Now, she’s lending her voice to the call for more information to be shared between the FDA, doctors and patients.

Jamee Cook was 21, engaged to be married and a paramedic when she made a decision that would shape the rest of her life.

“I was really active. Healthy, Young, skinny,” she said. “I was always really really flat chested and wanted to be more proportionate.”

At age 21, Cook chose to get breast implants. At 40, it is her biggest regret.

“I mean, I made this decision and I own it,” she said. “And I do feel guilty about it because it took a lot of things away from me.”

She says that included her health. Three years after surgery she developed an auto immune disease.

“Then it went downhill, just chronic fatigue, swollen lymph nodes all the time, chronic sinus infections,” Cook said. “I couldn’t get out of bed, I was having migraines two or three times a week, and I had three young kids at home!”

She says doctors had no more answers, which left her feeling helpless. Cook turned to the internet and researched, and she came to realize her implants could be the source. She was certain when she removed them after 17 years.

“I still battle fatigue off and on, but the majority of my other symptoms went away immediately,” she said.

Cook then gained new purpose. She created the group Breast Implant Victim Advocacy, a community of thousands women who say implants made them ill. She lobbied for implant safety in Washington. All of it, driven by a simple goal.

“I think that a lot of women don’t get the information they need to make a fully informed decision,” she said.

Last year, the American Society for Aesthetic Plastic Surgery said surgeons performed 333,329 breast augmentations. We asked Dallas plastic surgeon Dr. Lawrence Weider about what warnings patients can currently expect to hear from their doctors.

“There’s a whole host of risks that we discuss,” said Dr. Weider. “We have a several page consent for that we go through with them.”

But Cook argues there’s more to be done. Right now, The FDA is researching the ties between a specific type of implant causing a rare lymphoma, and last month a woman suffering from that cancer sued an implant maker in California. […]

Read the original article here.

How to Appeal a Denial


If you disagree with your health insurer’s decision to not cover a service, you have the right to appeal this decision. Many appeals are approved. Some appeals are handled by your healthcare provider, but you can also appeal a decision yourself.

Follow these steps to file an appeal:

1. Gather all relevant information

The first step to appealing your insurer’s decision is to find out why your claim was denied. Get a copy of your denial letter and any document(s) submitted to your insurance as a part of the initial claim. This might include documents such as MRI findings, lab test results, operative reports, notes from your physician(s), letters of medical necessity, or medical bills related to the claim.

You should check your denial letter to find out when the deadline to file the appeal is. Your denial letter should explain when and how to file the appeal.

You will also want to get a copy of your insurance’s Evidence of Coverage document (sometimes called the benefit policy document). From this document you can determine what procedures your plan covers.

It can also be helpful to call the insurance company’s member services phone number. You can ask them for a detailed explanation of why the procedure was denied. If you can’t get a clear explanation that makes sense to you, you can ask to speak to a supervisor. Always ask the name of the people you speak with on the phone, write it down with the date you talk to them, and ask them to “put it in the record” that you’re working on disputing the claim.

2. File an appeal form or write an appeal letter

It is likely that your insurance company will have a standardized appeal form for you to fill out. If so, filling out their form will make the process move as quickly as possible. This form usually asks for most of the information you would include in an appeal letter.

If your insurance company does not have a standardized appeal form, you need to write an appeal letter asking your insurance company to reconsider their decision.   Even if your insurance company has a standardized appeal form, an appeal letter can sometimes add more persuasive evidence.

This is known as an internal appeal. If the internal appeal is denied, you can appeal for a review by an independent third party. This is called an external appeal. The decision made by the external board is usually final and can’t be appealed.

The appeal letter should include the following:

  • Your identification: your name, claim number, policy number, member ID number and any other information that will help identify you.
  • Reason for denial: quote the exact reason for denial that they explained in the denial letter.
  • Reason why you disagree with the denial: explain why you think the procedure should be covered. To make your case stronger, you can insert relevant language from your insurance policy document that indicates the procedure should be covered. You can also get a letter from your doctor explaining why the procedure is medically necessary and include medical document(s) that prove medical necessity.
  • What you are requesting: Ask them to reconsider the denial and approve your claim based on the information you provided in the letter.

Click here for a sample appeal letter.

3. Contact your state’s Department of Insurance

If you need help filing an appeal, you can contact your state’s Department of Insurance for help. You can also contact them if you need to file a complaint against your insurance company. Click here to find your state’s Department of Insurance website.

Please contact the Breast Implant Information project for help filing an appeal at info@breastimplantinfo.org.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.

Sample Appeal Letter

Here is a sample appeal letter written for a woman with severe capsular contracture and a ruptured implant who was denied coverage for her breast implant removal surgery. For help writing your own appeal letter, contact us at info@breastimplantinfo.org. Click here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

April 6, 2018

XYZ Claims Department
Attention: Appeals
167 Daisy Lane
Milwaukee, OK 12345

RE: Appeal for Denial of Claim Submitted by Jane Doe

Group/Policy number: 1425-2345-1234
Date(s) of service: February 31, 2018

Dear XYZ Claims Department:

I am writing on behalf of my patient, Jane Doe, to appeal XYZ’s decision to deny coverage for her breast implant removal surgery. I recommended the surgery because Ms. Doe has severe capsular contracture, which is causing her severe pain, restricting her movements, and interfering with mammography. In addition, her right implant is broken.

Your denial letter dated November 3, 2017, states that coverage for this procedure was denied because Ms. Doe’s “current condition does not meet the needed requirements and a bilateral breast revision is not medically necessary.” According to your letter, that determination was based on XYZ’s Coverage Criteria #567 and the details of her case. Your review concluded that because Ms. Doe has “not had breast cancer surgery or a breast injury,” you cannot approve the request for explant surgery.

We respectfully ask you to reconsider that decision. According to page 23 of my patient’s XYZ Medical Policy document (copy enclosed), Ms. Doe’s plan covers all “medically necessary” services that are not expressly excluded. Her plan does exclude cosmetic procedures; however, Ms. Doe’s implant removal is NOT a cosmetic procedure. Although Ms. Doe initially had the implants placed for cosmetic reasons, I recommended permanent removal solely to treat her present medical condition.

A review of XYZ’s Coverage Criteria #567 confirms my view that removal of her implants should be considered medically necessary. The guideline states:

Removal of breast implants for any of the following conditions may be medically necessary:
– Broken or failed implant;
– Infection;
– Implant extrusion;
– Siliconoma or granuloma;
– Interference with breast cancer;
– Breast pain; and
– Painful contraction”

Ms. Doe meets several of the above-stated criteria. I diagnosed her with Baker Grade IV capsular contracture (i.e. “painful contraction”) in her left breast, which is causing her chronic pain, restricting her movements, and interfering with mammography. Because of the pain, Ms. Doe regularly takes pain medication. Additionally, the MRI detected that Ms. Doe’s right silicone gel implant has broken (failed).

Consequently, based on the aforementioned language of the XYZ Medical Policy document and XYZ Coverage Criteria #567, XYZ should consider Ms. Doe’s implant removal a medically necessary procedure. Surgical removal of breast implants is the standard medical treatment for severe capsular contracture. The surgery is not intended to improve her appearance, rather it is intended to relieve her pain and restore her functioning. There is no other equally effective treatment available to Ms. Doe that is more conservative or less costly. Without removal, Ms. Doe will continue to experience severe pain and restricted movement, and her capsular contracture will make future screening mammograms difficult, if not impossible.

Based on this information, I request that you reconsider your denial and approve coverage for Jane Doe’s breast implant removal surgery. For your convenience, I have enclosed copies of all Ms. Doe’s relevant medical records. If you need additional information, please do not hesitate to contact me at (111) 111-1111 or doctor@iworkhere.org.

Thank you for your immediate attention to this matter.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s XYZ Medical Policy
Ms. Doe’s Office Visit Notes from 11/21/2017
MRI Report from 12/10/2017
Ms. Doe’s post-operative report from 2/31/2018


	

Sample Letter of Medical Necessity

Here is a sample letter of medical necessity written for a woman with ruptured silicone gel implants and severe capsular contracture. For help writing your own letter of medical necessity, contact us at info@breastimplantinfo.orgClick here to download.


Breast Implant Removal Office
555 Smiles Way
Healthytown, DC 55555

January 5, 2018

XYZ Claims Department
167 Daisy Lane
Milwaukee, OK 12345

RE: Letter of Medical Necessity for Jane Doe

Group/policy number: 1425-2345-1234
Date(s) of service: January 2, 2018

Dear XYZ Claims Department:

I am writing on behalf of Jane Doe, to document medical necessity and request prior-authorization for explantation of two silicone gel breast implants. Ms. Doe is a 56-year-old female with rupture of her right implant, Baker level III capsular contracture in her left implant, and significant pain in both breasts. She has been in my care since September 21, 2017. Ms. Doe requires an explantation with permanent removal of both implants.

As a result of her pain, Ms. Doe has experienced significant deficits in her daily functioning, including not being able to reach above her head, get dressed, or drive to work. She has previously taken a variety of over-the-counter and prescription pain medications, which have not alleviated her pain. The attached medical records document Ms. Doe’s clinical condition and medical necessity for permanent explantation of both breast implants. There is no equally effective course of treatment available for this patient that is more conservative or less costly.
My patient’s XYZ policy states the following:

“Removal of breast implants that were initially placed for cosmetic purposes is covered when it is considered medically necessary to treat illness or restore the functioning of a body part.”

According to the medical policy of XYZ, Ms. Doe’s breast implant removal should be covered because she has severe capsular contracture that interferes with her daily functioning and has interfered with mammography. Removal of her breast implants and scar tissue surrounding them should relieve her breast pain and eliminate her capsular contracture.

Surgical implant removal is the standard treatment for severe capsular contracture and ruptured silicone-gel breast implants, and this procedure is clinically appropriate for my patient’s condition. Based on the language above, this procedure should be considered medically necessary.

I ask that you take the above information into consideration and offer coverage for Ms. Doe’s medically necessary explant surgery. Should you require additional information, please feel free to contact me at (111) 111-1111 or doctor@iworkhere.org.

Sincerely,

Dr. David Healthcare, Chief of Breast Implant Removal Operations
NPI# 1234567890

Enclosures:
Ms. Doe’s Office Visit Notes from 9/21/2017
MRI Report from 11/10/2017
Ms. Doe’s post-operative report from 1/2/2018

Breast Pain, Redness, or Swelling


You may experience breast pain immediately after your surgery or years after your surgery. It’s important to find out what is causing your breast pain so that you can try to reduce it.

As with any surgery, augmentation patients should expect to feel pain immediately after surgery. However, pain that lasts for months or longer can have many different causes and requires treatment. It can be a sign of an infection, especially if the pain is accompanied by redness, swelling, and tenderness.

Pain can also be caused by capsular contracture, which is when scar tissue that has developed around the implant tightens or hardens. The breast will feel hard and may change shape. The more severe the capsular contracture becomes, the more pain you will experience.

Nerve injury can also cause chronic breast pain or loss of sensation (numbness) of the breast and nipples. Studies have found that between about 13 and 15% of augmentation patients experienced nerve injury or changes in sensation after surgery. Damaged nerves heal slowly and may not ever heal. If the nerve injury is severe enough, additional surgery may be recommended.

Swelling in the breast can be caused by infection, rupture, an inflammation, or Anaplastic Large Cell Lymphoma (ALCL), a cancer of the immune system. If you notice swelling in your breasts, your doctor should test the fluid around your implant for signs of bacteria or signs of cancer.

All articles have been reviewed and approved by Diana Zuckerman, PhD,  and other senior staff.

Autoimmune Symptoms


Breast implant companies were required to complete safety studies before they could sell their implants in the United States. Although the Food and Drug Administration (FDA) approved breast implants, they admitted that “studies would need to be larger and longer” to find out if implants could cause the kinds of diseases many women were reporting.1

Since many women reported problems with autoimmune or connective tissue disorder symptoms such as joint pain, breast implant companies did not study the safety of implants in women who had a family history or personal history of autoimmune disease before getting implants. They intentionally excluded those women because they were concerned that those women might be more likely to have health problems from the implants. Breast implant companies recognize this as a shortcoming of their studies. For example, this is what Mentor says in their label for MemoryGel® implants:2

Safety and effectiveness have not been established in patients with the following:

  • Autoimmune diseases (for example, lupus and scleroderma)…”

Unfortunately, most physicians and most women considering implants are unaware of that warning.

What Is Autoimmune Disease?

Autoimmune disease is a condition where immune cells attack your body. Immune cells usually help our bodies fight off infections and foreign substances. However, these immune cells see silicone as a foreign substance, and that can cause the body to start an immune response.

In some cases, the immune system launches a big enough attack that it starts attacking the body. This could lead to symptoms like joint pain, fatigue, mental confusion, dry eyes, and hair loss. Some women with breast implants report a wide range of symptoms that do not fit into one specific condition. Over time, some women develop a pattern of symptoms that are diagnosed as lupus, scleroderma, or other conditions. Autoimmune diseases can target specific organs, like the brain or liver. They can also involve many tissues, like muscles or blood.3

It is important to know that not all people who get breast implants develop immune problems. Those who develop autoimmune symptoms may have other risk factors, such as allergies or a family history of autoimmune disease.4 In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants. Certain genes may also increase the chances of developing autoimmune diseases or symptoms, sometimes as a reaction to silicone or other exposures. In addition, women who already had autoimmune symptoms can get worse symptoms or new symptoms after getting breast implants.

Silicone-related complaints and diagnoses (modified from DeBoer et al, 2011) 

 

Silicone-related complaints

  • Fatigue
  • Muscle aches
  • Aching and painful joints
  • Fever/elevated body temperature
  • Dry eyes, dry mouth (sicca)
  • Poor memory, concentration, or sleep
  • Stroke
  • Numbness, weakness, dizziness, vision changes (Multiple sclerosis)
 

  Silicone-related diagnoses

  • Raynaud’s disease (painful cold, pale, or purplish fingers and toes)
  • Irritable bowel syndrome (diarrhea, constipation)
  • Allergies (food allergies, metal allergies, multiple sensitivities, etc.)
  • Immunodeficiencies (recurrent infections, e.g., pneumonia, sinus infections, diarrhea)
  • Autoimmune diseases (Scleroderma, Lupus, Sjogren’s, etc.)

How “Good” Is the Evidence?

There is conflicting evidence from studies that examined whether breast implants cause autoimmune disease or symptoms. Most studies were funded by implant companies or plastic surgery associations, and they tend to focus on narrowly defined diagnoses, with numerous studies based on hospital records rather than medical records. However, many women with breast implants have reported the same complaints over the last few decades, and many women report that their symptoms greatly improved or completely disappeared after their implants were removed.5

In 2001, FDA scientists reported that women with leaking silicone gel implants were nearly 3 times more likely to have fibromyalgia. Fibromyalgia is a disorder that causes widespread pain in the body as well as fatigue. Little is known about how fibromyalgia develops, but researchers think it is an immune system problem.         

In 2004, scientists from the National Cancer Institute reported that women with breast implants were more likely to have autoimmune symptoms. However, because symptoms were self-reported, the scientists concluded that more research was needed to determine if breast implants caused specific symptoms or diseases.6

In recent years, the discovery that breast implants could cause cancer of the immune system (ALCL) supports the claim that breast implants can have a harmful impact on the immune system.

The Bottom Line

Although well-designed large, long-term studies are lacking, women with implants and autoimmune symptoms have reported for decades that their symptoms improved when their implants were removed. A Dutch study found that among 52 women who had their implants removed, 36 (69%) reported that they felt better, and 9 of the 36 reported that their symptoms were gone. A meta-analysis, which is a type of study that combines the results from several studies, found that on average, 3 out of 4 women who removed their silicone breast implants saw improvement in their symptoms.

However, the prognosis might be better for women with autoimmune symptoms who have their implants removed than for women with a diagnosed autoimmune disease.

Treatments and Alternatives

Here are some symptoms that many women have reported to have developed after getting breast implants.  Some of these symptoms developed almost immediately, but others developed years later.

  • I have achy, sore, or weak muscles.
  • I have achy or stiff joints.
  • I wake up every morning feeling tired or un-refreshed, and no matter how much I sleep, I never feel well-rested.
  • I feel like my head is in a “fog.” I have difficulty concentrating, finding the right word to say, or remembering things.
  • I feel warm or hot even when it’s cold outside.
  • I have dry skin, dry eyes, or hair loss.

If you already have an autoimmune disease, breast implants could make your symptoms worse. If autoimmune disease runs in your family, you may be at increased risk of developing an autoimmune reaction to the silicone implant. If you already have breast implants and have any of the above symptoms, here are some steps to consider:

  • See a rheumatologist. A rheumatologist is a specialist of joint and immune system conditions. The rheumatologist can examine you and order tests if necessary to potentially diagnose any conditions. See a provider you trust and don’t be afraid to get a second opinion. This is your right as a patient!
  • Your doctor may offer you medications to treat your symptoms. For example, he/she may offer you artificial tears to help with dry eyes or suggest medications to decrease inflammation in your body.

All articles are reviewed and approved by Diana Zuckerman, PhD, and other senior staff.